- ISO 10993-17
- ISO 10993-18
- USP 661
Nelson Labs offers vast and successful experience in developing, implementing, interpreting, and reporting chemical assessments, including extractables and leachables studies for medical devices and pharmaceutical products. Devising, executing, and reporting a customized approach, expertly tailored to address the safety issues specific for a particular medical device while addressing a particular client’s scientific and practical realities.
The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialty panels. Despite their great diversity in form and function, one performance characteristic is shared by all medical devices: medical devices should be designed and manufactured in such a way that they will not compromise the safety of patients or users when they are used under the conditions and for the purposes intended. Although this objective is clear, the means for actually establishing the safety of medical devices is ambiguous and incompletely addressed in regulatory guidelines.
To address this circumstance, the International Organization for Standardization (ISO) created a series of international standards, under the ISO 10993 umbrella, which together establish the means for biologically evaluating medical devices. Specifically, the primary aim of the ISO 10993 series of standards is the protection of humans from potential biological risks arising from the use of medical devices.
Chemical testing has a key role in the ISO 10993 evaluation process. As noted in section 4.3 of part 1, “Identification of material chemical constituents and consideration of chemical characterization (see ISO 10993-18) shall precede any biological testing.” Moreover, a greater emphasis is being placed on chemical assessment as a means of augmenting and even replacing certain biological tests, addressing the various technical and practical issues associated with biological testing.
Two parts of the ISO 10993 series are relevant to chemical assessment, Part 18 (Chemical characterization of materials) for the generation of chemical information (including extractables and leachables data) and Part 17 (Establishment of allowable limits for leachable substances) for the safety interpretation of extractables and leachables data.
Although Part 18 provides a framework for chemical assessment and contains useful information for performing the chemical testing that is the basis of the chemical assessment, Part 18 is neither a prescriptive cookbook nor a procedure specification that provides exact instructions for every step required in performing the necessary tests. Thus, for example, while Part 18 specifies the need to perform extractables testing and provides general advice on aspects to consider when designing and implementing an extraction study, it does not contain a standard extraction protocol.
The practical consequences of a poor chemical assessment are significant, measured in lost time, excessive costs, and delays in securing regulatory approvals. Nelson Labs ensures testing related to medical devices is expertly tailored to address the safety issues specific for a particular medical device while addressing a particular client’s scientific and practical realities. Offering a comprehensive set of tests for characterization and screening of raw materials as well as extensive experience testing different types of plastics and polymers.
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If you have additional questions about Extractables & Leachables for Medical Devices, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.